Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT01243892
Description: Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
Frequency Threshold: 0
Time Frame: Baseline up to approximately 9 months
Study: NCT01243892
Study Brief: A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IGHD Participants IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. None None 1 15 0 15 View
ISS Participants ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. None None 0 3 1 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peripheral oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View